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NAME AND INTENDED USEThe OraQuicko HCV Rapid Antibody Test is a single-use immunoiassay for the qualitative detection of antibodies tohepatitis C virus (anti-HCV) in venipuncture whole blood specimens (EDTA, sodium heparin, lithium heparin, andsodium citrate) from individuals .15 years or older. The CraQuick"' HCV Rapid Antibody Test results, in conjunctionwith other laboratory results and clinical information, may be used to provide presumptive evidence of infectionwith H-CV (state of infection or associated disease not determined) in persons with signs or symptoms of hepatitisand in persons at risk for hepatitis C infection.

Warning: This assay has not been FDA approved for use in patient populations without signs, symptoms, ornot at risk for hepatitis C infection.

Not for use in screening whole blood, plasma, or tissue donors. Performance characteristics have not beenestablished for testing a pediatric population less than 15 years of age or for pregnant women.

SUMMARY AND EXPLANATION OF THE TESTHepatitis C virus is a single-stranded ribonucleic acid RNA virus responsible for most, if not all non-A, non-Bhepatitis.2 HCV is primarily transmitted by contact with contaminated blood, blood products, or through other closepersonal contact.3 The presence of antibodies to HCV indicates that the individual may be currently infected andcapable of transmitting the virus.

The OraQuick®' HCV Rapid Antibody Test utilizes an indirect lateral flow immunoassay method to detect antibodiesto both structural and non-structural HCV proteins. The device utilizes synthetic peptides and recombinant antigensfrom the core, NS3, and NS4 regions of the HCV genome, that are immobilized as a single test line on the assaystrip. Antibodies reacting with these peptides and antigens are visualized by colloidal gold labeled with protein Agenerating a visible line in the test zone for a reactive sample.

PRINCIPLES OF THE TESTThe OraQuick® HCV Rapid Antibody Test is a manually performed, visually read immunoassay for the qualitativedetection of HCV antibodies in human venipuncture whole blood. The OraQuick® HCV Rapid Antibody Test 'iscomprised of both a single-use test device and vial containing a pre-measured amount of a buffered developersolution. The test consists of a sealed pouch with two separate compartments for each component. The OraQuick®HCV Rapid Antibody Test utilizes a proprietary lateral flow immunoassay procedure.

The assay test strip, which can be viewed through the test device result window, contains synthetic peptides andrecombinant proteins from the core, NS3, and NS4 regions of the HCV genome (test) and a goat anti-human IgG(procedural control) immobilized onto a nitrocellulose membrane at the Test (T) and the Control (C) Zone,respectively.

A venipuncture whole blood specimen is collected using a specimen loop and transferred into the developer solutionvial, followed by the insertion of the device. The developer solution facilitates the capillary flow of the specimeninto the device and onto the assay strip. As the specimen flows through the device, antibodies from the specimen arebound to the protein A gold colorimetric reagent present on the assay strip. If the specimen contains anti-HCVantibodies, the resulting labeled complexes contain HCV antibody and bind to immobilized HCV antigens at theHCV Test Zone (T Zone) resulting in a reddish-purple line. If the specimen does not contain anti-HCV antibodies,the labeled complexes do not bind at the HCV Test Zone and no line is observed in the T Zone. The intensity of theline color is not directly- proportional to the amount of HCV antibody present in the specimen. The remaininglabeled complexes are transported to the Control Zone (C Zone) binding to a goat anti-human antibody fragment.The presence of IgG antibodies in the sample (regardless of their specificity) results in a reddish-purple line at the CZone. This procedural control serves to demonstrate that a specimen was added to the vial and that the fluid hasmigrated adequately through the device. A reddish-purple line will appear at the C Zone during the performance ofall valid tests; whether or not the sample is positive or negative for HCV antibodies (refer to the Test Result andInterpretation of Test Result section in this package insert).

The test results are interpreted after 20 minutes, but not more than 40 minutes following the introduction of thedevice into the developer solution vial. No precision pipetting, pre-dilutions, or specialized instrumentation arerequired to perform the OraQuick ® HCV Rapid Antibody Test.

MATERIALS PROVIDEDOraQuick ® HCV Rapid Antibody Test Kits are available in the following packaging configurations:

Components of Kit 25 Count Kit 100 Count KitCatalog Number 1001-0181 1001-0180Divided Pouch, 25 100Each containing:Test Device (1)Absorbent Packet (1)Developer Solution Vial (1)(each vial contains 0.750 mL of abuffered saline solution with anantimicrobial agent)Reusable Test Stands 5 10Specimen Collection Loops 25 100Package Insert I

MATERIALS REQUIRED AND AVAILABLE AS AN ACCESSORY TO THE KITOraQuick ® HCV Rapid Antibody Test Kit Controls 1001-0182Package contains:HCV Positive Control (1 vial, purple cap, 0.2 mL),HCV Negative Control (I vial, white cap, 0.2 mL), andPackage Insert.

MATERIALS REQUIRED BUT NOT PROVIDEDTimer or watch capable of timing 20 to 40 minutesBiohazard waste containerMaterials required for venipuncture whole blood specimen collection

RESTRICTIONS* Sale of the OraQuick® HCV Rapid Antibody Test is restricted to healthcare professionals:

- that have an adequate quality assurance program, including planned systematic activities to provideadequate confidence that requirements for quality will be met; and

- where there is assurance that operators will receive and use the instructional materials.* This assay has not been FDA approved for use in patient populations without signs, symptoms, or not at

risk for hepatitis C infection.* Not for use in screening whole blood, plasma, or tissue donors. Performance characteristics have not

been established for testing a pediatric population less than 15 years of age or for pregnant women.

WARNINGSFor In vitro Diagnostic Use* This package insert must be read completely before using the product.* Follow the instructions carefully when performing the OraQuick® HCV Rapid Antibody Test, failure to

do so may cause an inaccurate test result.* Before proceeding with testing, all operators MUST read and become familiar with Universal

Precautions for Prevention of Transmission of Human Immunodeficiency Virus, Hepatitis A Virus,Hepatitis B Virus, and other Bloodborne Pathogens in Health-Care Settings.

* This kit has been approved for use with venipuncture whole blood specimens only. Use of this test kitwith specimen types other than those specifically approved for this device may cause inaccurate testresults.

* This test is not intended to be used to monitor individuals who are undergoing treatment* This test should be performed at temperatures in the range of 150-370C (590-99 0 F). If stored refrigerated,

ensure that the Divided Pouch is brought to operating temperature (150-370 C, 590 -990 F) beforeperforming testing.

* Do not use if the test kit is exposed to temperatures outside of the recommended storage temperature (2o-

300C, 360 -860F), or is tested outside of the operating temperature (150 -370C, 590 -990 F). \%

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PRECAUTIONSSafety Precautions* Handle specimens and materials in contact with specimens as if capable of transmitting infectious agents.* Wear disposable gloves while handling and testing blood specimens. Change gloves and wash hands thoroughly

after performing each test. Dispose of used gloves in a biohazard waste container.* For additional information on biosafety, refer to "Universal Precautions for Prevention of Transmission of

Human Immunodeficiency Virus, Hepatitis A Virus, Hepatitis B Virus, and other Bloodborne Pathogens inHealth-Care Settings"' and "Updated U.S. Public Health Service Guidelines for the Management ofOccupational Exposures to HBV, HCV, and HIV and Recommendations for Postexposure Prophylaxis". 4

Device Handling Precautions* Use all Specimen Collection Loops, Test Devices, and Developer Solution Vials only once and dispose of

properly (see Safety Precautions). Do not reuse any of these test components.· Do not use the test beyond the expiration date printed on the Divided Pouch. Always check expiration date prior

to testing.* Inspect the Divided Pouch. If the Divided Pouch has been damaged, discard the Divided Pouch and its contents

and select a new Divided Pouch for testing.* Do not interchange Test Devices and Developer Solution Vials from kits with different lot numbers.* Avoid microbial contamination and exercise care in handling the kit components.

To ensure accurate results, the Test Device must be inserted into the Developer Solution Vial within 60 minutesafter introducing the specimen into the Developer Solution.Adequate lighting is required to read a test result.

STORAGE INSTRUCTIONSStore unused OraQuick ® HCV Rapid Antibody Tests unopened at 20 -30°C (360 -86°F). Do not open the Divided

Pouch until you are ready to perform a test. If stored refrigerated, ensure that the Divided Pouch is brought tooperating temperature (150-37 0 C, 59 0-990 F) before opening.

DIRECTIONS FOR USE ma Chrambm

GENERAL TEST PREPARATION

1. Follow Safety Precautions section in this package insert.2. Gather the materials ou will need.3. Allow the OraQuick HCV Rapid Antibody Tests to come to operating

temperature (150-37°C; 59°-99°F) before use.4. Refer to the External Quality Control section in this package insert to

determine when the Kit Controls should be run. /5. Set an OraQuick ® Reusable Test Stand at your workspace, using only

the stand provided.6. Open the two chambers of the OraQuick®' Divided Pouch

by tearing at the top notches located on each sideof the Pouch (see picture I and 2). To preventcontamination, leave the Test Device in thePouch until you are ready to use it.

7. Remove the Developer Solution Vial from the Pouch.Hold the Developer Vial firmly in your hand. Removethe cap from the Developer Vial by gently rocking the cap back and forthwhile pulling it off. Set the cap aside. Slide the vial into the top of the slots in the Reusable Test Stand. (see

picture 3).

NOTE: DO NOT cover the two holes in the back of theDevice with labels or other materials, as it maycause an Invalid test result (seepicture 4).

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SPECIMEN COLLECTION AND TESTINGPROCEDUREThe OraQuick® HCV Rapid Antibody Test can be used fortesting venipuncture whole blood specimens. Refer to thespecific testing procedure below.

VENIPUNCTURE WHOLE BLOOD PROCEDURESTEP 1: COLLECT1. Using standard venous phlebotomy procedures collect a

whole blood specimen using a tube containing any of thefollowing anticoagulants: EDTA, sodium heparin, lithiumheparin, or sodium citrate. Other anticoagulants havenot been tested and may cause an inaccurate result. Ifthe specimens are not tested at the time of collection, thewhole blood may be stored at 20-8°C (36°-460 F) for up to7 days or at 15'-30°C (59°-86°F) for up to 3 days.

2. Prior to testing, mix the blood tube gently by inversionseveral times to ensure a homogeneous specimen. Obtainan unused Specimen Collection Loop by the handle (seepicture 5). Insert the rounded end of the Loop into thetube of blood (see picture 6), and verify that the Loop iscompletely filled with blood (see picture 7). NOTE: Ifthe Loop is dropped or comes in contact with any othersurface, discard it in a biohazard waste container. Use anew Loop for the collection of the blood specimen.

STEP 2: MIXI. Immediately insert the blood-filled end of the Loop all the

way into the Developer Vial (see picture 8). Use the Loopto stir the blood sample in the Developer Solution (see -picture 9). Remove the used Loop from the Solution anddiscard in a biohazard waste container.

2. Verify that the Solution is pink in color, indicating thatthe blood was thoroughly mixed into the Solution (seepicture 10). If the Solution is not pink, discard all testmaterials in a biohazard waste container. Start the testover using a new Pouch and a new blood sample. NOTE:To ensure accurate results, the Test Device must beinserted into the Developer Solution Vial within 60minutes after introducing the specimen into the DeveloperSolution.

STEP 3: TESTI.Remove the Device from the Pouch. DO NOT touch the

Flat Pad (see picture I1). Verify that an Absorbent Packetis included with the Device (see picture 12). If noAbsorbent Packet is present, or if the Absorbent Packet isdamaged, discard the Device and obtain a new Pouch fortesting.

2. Insert the Flat Pad of the Device all the way into theDeveloper Vial containing the blood sample (seepicture13), and verify that the Flat Pad touches the bottom of theDeveloper Vial. The Result Window on the Deviceshould be facing towards you (see picture 14).

3. Start timing the test (see picture 15). DO NOT removethe Device from the Developer Vial while the test isrunning. A pink color will migrate up the Result Window,and will gradually disappear as the test develops (seepicture 16). Read the result in a fully lighted area after 20minutes, but no more than 40 minutes.

4. Refer to the Test Result and Interpretation of Test Resultsection in this package insert.

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GENERAL TEST CLEAN-UP1. Dispose of the used test materials and gloves in a biohazard waste container.2. When using gloves, change your gloves between each test to prevent contamination.3. Use a freshly prepared 10% solution of bleach to clean up any spills.5

QUALITY CONTROLBuilt-in Control FeaturesThe OraQuick® HCV Rapid Antibody Test has a built-in procedural control that demonstrates assay validity. Areddish-purple line in the Control Zone (C Zone) of the Result Window indicates that a specimen was added and thatthe fluid migrated appropriately through the Device. The Control line will appear on all valid tests, whether or notthe sample is reactive or non-reactive for anti-HCV (Refer to Test Result and Interpretation of Test Result section inthis package insert).

External quality ControlOraQuick HCV Rapid Antibody Test Kit Controls are available separately for use only with the OraQuick® HCVRapid Antibody Test. The Kit Controls are specifically formulated and manufactured to ensure proper performanceof the test. The HCV Positive Control will produce a reactive reddish-purple line at the Test Zone (T Zone). TheHCV Negative Control will generate a non-reactive test result (no reddish-purple line at the T Zone). Refer to TestResult and Interpretation of Test Result section in this package insert. Use of kit control reagents manufactured byany other source will not meet the requirements for an adequate quality assurance program for the OraQuick ® HCVRapid Antibody Test.

Additional controls may be tested according to guidelines or requirements of local, state, and /or federal regulationsor accrediting organizations.

Run the Kit Controls under the following circumstances:Each new operator prior to performing testing on patient specimens,

* When opening a new test kit lot,* Whenever a new shipment of test kits is received,

If the temperature of the test kit storage area falls outside of 2°-30°C (360 -86 0F),If the temperature of the testing area falls outside of 15°-370 C (590 -99°F), and

* At periodic intervals as dictated by the user facility.

Refer to the OraQuick® HCV Rapid Antibody Test Kit Controls package insert for instructions on the use of thesereagents. It is the responsibility of each laboratory using the OraQuick HCV Rapid Antibody Test to establish anadequate quality assurance program to ensure the performance of the device under its specific locations andconditions of use. Contact OraSure Technologies' Customer Service if the Kit Control reagents do not produce theexpected results.

TEST RESULT AND INTERPRETATION OF TESTRESULTRefer to the Result Window on the Test Device.

NON-REACTIVEA test is Non-Reactive if:

a line appears in the C Zone and NO line appears in the TZone (see picture 17).

A Non-Reactive test result means that HCV antibodies werenot detected in the specimen. Patient is presumed not to beinfected with HCV.

REACTIVEA test is Reactive if:

a line appears in the C Zone and a line appears in the TZone. Lines may vary in intensity. The test Is reactiveregardless of how faint these lines appear (see pictures 18,19 and 20).

A Reactive test result means that HCV antibodies have beendetected in the specimen. Patient is presumed to be infectedwith HCV.

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Individuals with a reactive result in the OraQuick® HCV Rapid Antibody Test should undergo appropriate clinicalfollow-up, according to CDC recommendations for supplemental testing.6

INVALIDA test is Invalid if:

* NO line appears in the C Zone (see picture 21), or• a pink background obscures the results during the 20-to 40 minute read times (see picture22), or

* any partial line on one side of the C or T Zones (seepictures 23 and 24).

An Invalid test result means that there was a problem runningthe test, either related to the specimen or to the Device. AnInvalid result cannot be interpreted. Repeat the test with anew Pouch and a new specimen. Contact OraSureTechnologies' Customer Service if you are unable to get avalid test result upon repeat testing.

LIMITATIONS OF THE TESTI. The OraQuick® HCV Rapid Antibody Test must be used in accordance with the instructions in this package

insert to obtain an accurate result.2. Reading test results earlier than 20 minutes or later than 40 minutes may yield inaccurate test results.3. This test is approved for use with venipuncture whole blood specimens only. Use of other types of specimens,

or venipuncture whole blood specimens collected using a tube containing anticoagulants other than EDTA,lithium heparin, sodium heparin, or sodium citrate may yield inaccurate results,

4. Clinical data has not been collected to demonstrate the performance of the OraQuick® HCV Rapid AntibodyTest in individuals under 15 years of age.

5. A reactive result using the OraQuick HCV Rapid Antibody Test suggests the presence of HCV antibodies inthe specimen, and the intensity of the test line does not necessarily correlate with the HCV antibody titer in thespecimen. The OraQuick® HCV Rapid Antibody Test is intended as an aid in the diagnosis of HCV infection.

6. A non-reactive result does not exclude the possibility of exposure to HCV or infection with HCV. An antibodyresponse to recent exposure may take several months to reach detectable levels.

7. A person who has HCV antibodies is presumed to be infected with the virus. Additional testing and medicalevaluation is required to determine the state or associated disease.

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EXPECTED RESULTS FOR THE INTENDED USE POPULATIONOf the 1207 specimens tested in two OraQuick ® HCV Rapid Antibody Test clinical studies, 88.2% (1064/1207)were from subjects at risk for hepatitis C infection but were asymptomatic and reported no current signs orsymptoms of hepatitis, and 11.8% (142/1207) were from subjects with current signs or symptoms of hepatitis. One(1/1207) pregnant subject was enrolled without signs or symptoms of hepatitis or risk factors for hepatitis Cinfection. The 1207 individuals were enrolled from the following collection locations:

* 50.3% from Miami, FL * 10.7% from Allentown, PA* 24.7% from Ft. Lauderdale, FL * 0.7% from College Park, MD, San Francisco,* 13.6% from Fall River, MA CA, Dallas TX, and Philadelphia, PA.

The OraQuick ® HCV Rapid Antibody Test was reactive in 36.7% (443/1207) of subjects tested. There were noinvalid OraQuick® HCV Rapid HCV Antibody Test results reported for the 1207 specimens tested (0/1207, 95%Cl: 0.0%, 0.3%). Of the 1207 individuals tested, 33.1% (400/1207) were also self-reported HIV positive. Thetable below summarizes the distribution of OraQuick® HCV Rapid Antibody Test reactive, non-reactive, andinvalid results for the 1207 specimens tested.

OraQuick ® HCV Rapid Antibody Test Results in High Risk IndividualsAge Gender No signs or symptoms Signs or symptoms

Range Reactive Non-Reactive Invalid Total Reactive Non-Reactive Invalid Total11n (%) n (%) n (%) (n) n (%) n( % ) n (%) (n)

F 0 (0.0) 0 (0.0) 0 (0.0) 0 0 (0.0) 0 (0.0) 0 (0.0) 0M 0 (0.0) 0 (0.0) 0 (0.0) 0 0 (0.0) 0 (0.0) 0 (0.0) 0F 0 (0.0) 11 (1.0) 0 (0.0) 11 1(0.7) 1 (0.7) 0 (0.0) 2

1 9 M 0 (0.0) 14 (1.3) 0 (0.0) 14 0 (0.0) 1 (0.7) 0 (0.0) IF 11 (1.0) 29 (2.7) 0 (0.0) 40 1 (0.7) 9 (6.3) 0 (0.0) 10M 7(0.7) 50(4.7) 0(0.0) 57 1 (0.7) 3 (2.1) 0 (0.0) 4F 15 (1.4) 44 (4.1) 0 (0.0) 59 4 (2.8) 18 (12.7) 0 (0.0) 22M 23 (2.2) 56 (5.3) 0 (0.0) 79 4 (2.8) 4 (2.8) 0 (0.0) 8F 53 (5.0) 97 (9.1) 0 (0.0) 150 7 (4.9) 8 (5.6) 0 (0.0) 15M 82 (7.7) 191 (18.0) 0 (0.0) 273 6 (4.2) 8 (5.6) 0 (0.0) 14F 41 (3.9) 38 (3.6) 0 (0.0) 79 3 (2.1) 5 (3.5) 0 (0.0) 8M 137 (12.9) 117 (11.0) 0 (0.0) 254 23 (16.2) 9 (6.3) 0 (0.0) 32F 6 (0.6) 5 (0.5) 0 (0.0) 11 1 (0.7) 9 (6.3) 0 (0.0) 10M 13 (1.2) 19 (1.8) 0 (0.0) 32 2 (1.4) 5 (3.5) 0 (0.0) 7F 0 (0.0) 0 (0.0) 0 (0.0) 0 0 (0.0) 4 (2.8) 0 (0.0) 4M I (0:1) 4 (0.4) 0 (0.0) 5 1 (0.7) 2 (1.4) 0 (0.0) 3F 0 (0.0) 0 (0.0) 0 (0.0) 0 0 (0.0) 1 (0.7) 0 (0.0) 1

80-89M 0 (0.0) 0 (0.0) 0 (0.0) 0 0 (0.0) 1 (0.7) 0 (0.0) 1

90-100 F 0 (0.0) 0 (0.0) 0 (0.0) 0 0(0.0) 0 (0.0) 0 (0.0) 0M 0 (0~.0) 0 (0.0) 0 (0.0)0 0 ( 0 0 0 (0.0) 0 0. 0 0

Total (N)* 389 (36.6) 675 (63.4) 0 (0.0) 1064 54 (38.0) 88 (62.0) 00 (0.0) 142* Does not include one pregnant woman enrolled without signs or symptoms of hepatitis or at risk for hepatitis C infection.

PERFORMANCE CHARACTERISTICSClinical PerformanceTwo multi-center prospective studies were conducted to evaluate the clinical performance of the OraQuick® HCVRapid Antibody Test in subjects with signs or symptoms of hepatitis and subjects at risk for hepatitis C infection.These risk factors included past or present intravenous drug use, having received a blood transfusion or organtransplant prior to 1992, evidence of high-risk sexual behavior, being born to an HCV positive mother, having beenon long-term hemodialysis, history of incarceration, and positive for HIV. Clinical performance was evaluated invenipuncture whole blood specimens from subjects prospectively enrolled at 8 geographically dispersed centerswithin the United States.

The population tested was African American (43.0%), Caucasian (37.7%), Hispanic/Latino (17.1%), as well as asmall proportion of other ethnic groups (2.2%). The mean age was 45 years (age range: 15 to 84 years). Of the1207 subject specimens tested, 436 were HCV infected, 762 were negative, and 9 specimens had the status of"Unable to Determine". HCV status was determined for each subject by EIA, with supplemental RIBA® and PCR

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assays as required. The table below summarizes the distribution of OraQuick ® HCV Rapid Antibody Test reactive,non-reactive, and invalid results in subject with HCV infected stats per the reference laboratory testing algorithm.

OraQuiek® HCV Sub iect HCV Infected StatusRapid Antibody Positive Negative Unable to Determine

Test Results I Infected StatusPositive 435 0 8Negative I 762 1Invalid 0 0 0

Positive and Negative Agreement CalculationsPercent positive and percent negative agreement between the OraQuick® HCV Rapid Antibody Test and HCV statuswere calculated overall for the population (n=1207), as well as for subjects with signs or symptoms of hepatitis andsubjects at risk for hepatitis C infection.

Percent Positive Agreement = Number of OraQuick® HCV Rapid Antibody Test Reactive Results x 100Total number of HCV Infected status

Percent Negative Agreement = Number of OraQuick® HCV Rapid Antibody Test Non-Reactive Results x 100Total number of HCV Not Infected status

For the purposes of calculating percent agreement, OraQuick® HCV Rapid Antibody Test reactive results forsamples whose HCV status was "Unable to Determine" following EIA with supplemental RIBA® and PCR testingwere considered "HCV Not Infected", and OraQuick® HCV Rapid Antibody Test non-reactive results for sampleswhose HCV status was "Unable to Determine" following EIA with supplemental RIBA® and PCR testing wereconsidered "HCV Infected".

Positive and Negative AgreementThe percent positive and negative agreement between the OraQuick® HCV Rapid Antibody Test and the subjectHCV Infected Status was calculated for the population (n=1207). Percent of invalid OraQuick® HCV RapidAntibody Test results was 0% (0/1207) with 95% Cl: 0.0% to 0.3%. Percent positive and negative agreement wasalso calculated for individuals with signs or symptoms of hepatitis (n=142); and for individuals at risk for hepatitis Cinfection (n=1064). Percent positive and negative agreement according to risk factors for HCV infection was alsocalculated. The risks for HCV were ranked on a clinical evaluation of the likelihood of acquiring hepatitis C, withthe most common given higher rankings.7 Each subject was assigned only one risk (the highest). Results with the95% confidence intervals are summarized in the following table.

Positive 95% Exact Negative 95% ExactStudy Subjects Total Percent Confidence Percent Confidence

Agreement Interval Agreement IntervalOverall 9207 98.4, 99.9 990% 98.0, 99.6

(435 / 437) (762 / 770Overall with signs or 142 100. 9 0 100.0% 95.9, 100.0%symptoms (54 / 54) (88 / 88)Overall without signs or 99.5%* 98.8%*symptoms (381 /383) (673 / 681)

99.3% 98.2%lVDU 456 (291 / 293) (160 94.7, 99.6

6 100% 2.5, 100.0 100.0% 47.8, 100.0Dialysis (1 / 1) (5/5)

100.0% 100.0% 100.0Transfusion/Transplant 63 79.4, 100.0 (47/47)6316 /716)10. 92.5, 100.0

461 100.0% 93.8. 100.0 98.8 97.1,99.6High Risk sex 6(58 / 58) 98 /0

2 1 000% 2.5, 100.0 100.0% 2.5, 100.0HCV positive mother ( 1 (I / 1)incarceration (10 /7151 1 004 4) 92.1, 100.0Prior history of 5(1100%)(5 4

§ 17 100.70 15.8, 100.0 10090% 78.2, 100.0HiV positive§ (2/2) 15 / 15

3100 2.5, 100.0% 15.8, 100.0None specified (I / 1) 2.5, ( (2 / 2)

Includes subjects with "unable to determine" status.

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sDoes not include 377 additional -IIV positive subjects enrolled but included in higher ranked risk categories, and 6 [HIV positive subjectsenrolled with sign~s or symptoms of hepatitis.

RESULTS OF SUPPLEMENTAL TESTING OF SPECIMENS REACTIVE IN THlE ORAQIJICKO HCV RAPID ANTIBODY TESTThe table below shows the results obtained when subjects reactive in the OraQuick® HCV Rapid Antibody Testwere tested by recombinant immunoblot assay (RIBA¶1.

Number of RIBA® Results*OraQuick Reactive

Results Positive Indeterminate Negative

443 418 25* 0

5Seventeen (17) of the RIBA" indeterminate results were positive for HCV RNA when tested byPCR.

Of the subjects reactive in the OraQuick® HCV Rapid Antibody Test 94.4% (4 18/443) were positive by RIBA®.Seventeen (17) of the RIBA® indeterminate results were positive for HCV RNA when tested by PCR; therefore,98.2% (435/443) were positive by either RIBA® or PCR.

REACTIVITY WITH IICV SEROCONVERSION PANELSEighteen panels containing sequential plasma specimens from individuals undergoing seroconversion as a result ofHCV infection were evaluated wi th the OraQuick®"HCV Rapid Antibody Test and compared with an FDA approvedanti-HCV BIA test. The OraQuick® H-CY Rapid Antibody Test and the reference anti-HCV assay results aresummarized in the following table. The sensitivity of the OraQuick® HCV Rapid Antibody Test to detectseroconversion was similar to that of the comparator EIA. The OraQuick® HCV Rapid Antibody Test detected anti-HCV antibodies earlier than EIA in 9 of the 18 seroconversion panels (50%) and by an overall average of 3.6 days(95% Cl = 1.2 to 5.9).

Days to Evidence of HCV Infection

Seroconversion OraQuick~' HCV Rapid FDA approved DifferencePanel Antibod Test anti-HCV EIA Oauc

Last First Last First (OrA)uckNon-Reactive Reactive Non-Reactive Reactive EA

HCV 6213 35 37 30 37 0HCV 6214 1 8 23 23 25 -2HCV 6227 46 74 46 74 0HCV 9041 3 1 62 3 1 62 0HCV 9046 0 69 0 69 0HCV 9047 21 28 21 28 0PHV 901 65 97 65 97 * 0PHV 905 7 1 1 1 1 18 -7PHV 907 7 1 3 1 3 1 8 -5

PHV910(M) 0 4 0 4 0PHV 9II (M) 0 11 0 11 0

PHV 914 9 12 19 24 -12PHV 916(M) 7 9 9 23 -14PHV 917(M) 22 85 22 85 0

PHV 920 7 13 7 16 -3PHV 921 0 4 4 1 4 -10

RPOO06 388 * 461 461 469 -8

RP 038 47 52 52 55-3Average _______ 59.2 6. -3.6 (-5.9 to -l.2)

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REACTIVITY WITH HCV SPECIMENS FROM VARIOUS GENOTYPES AND SUBTYPESThe ability of the OraQuick® HCV Rapid Antibody Test to detect infection derived from various genotypes and

subtypes was assessed using two commercially available Worldwide HCV Performance panels. Thirty-two HCV-positive plasma specimens derived from multiple geographies, representing four genotypes (1, 2, 3, 4) were tested.All specimens were reactive with the OraQuick® HCV Rapid Antibody Test. Three HCV-negative samples wereincluded in the panel and all were non-reactive with the OraQuick® HCV Rapid Antibody Test.

INTERFERING SUBSTANCESThe OraQuick® HCV Rapid Antibody Test was evaluated with the following interfering substances present in wholeblood, samples in order to assess their potential effect on the assay performance as per CLSI guidelines EP7-A2.Testing was completed on ten HCV-negative whole blood, samples and ten HCV-positive spiked matched whole

blood samples. All matched samples were spiked according to one of the following conditions as per the tablebelow:

Interfering Substances ConcentrationBilirubin 10 mg/dL

Hemoglobin 500 mg/dLLipid (Triolein) 3500 mg/dL

Protein 12 g/dL

None of these interfering substances had any impact on the OraQuick® HCV Rapid Antibody Test assayperformance at the concentrations evaluated.

MEDICAL CONDITIONS UNRELATED TO HCV INFECTIONThe performance of the OraQuick® HCV Rapid Antibody Test was evaluated with commercially available HCVnegative plasma and serum specimens derived from medical conditions unrelated to HCV infection. Results aresummarized in the table below.

Medical Condition Non-Reactive (%) Reactive (%)

Autoimmune Diseases

Myasthenia Gravis 4 4 (100) 0 (0)

Rheumatoid Arthritis 10 10 (100) 0 (0)

Systemic Lupus Erythematosus (SLE) lO0 10 (100) 0 (0)

Other Medical Conditions

Influenza Vaccination 10 10 (100) 0 (0)

Hepatitis A Virus (HAV) 59 59 (100) 0 (0)

Hepatitis B Virus (HBV) 58 58 (100) 0 (0)

Hepatitis D Virus (HDV) 2 2 (100) 0 (0)

Hepatitis E Virus (HEV) 8 8 (100) 0 (0)

Epstein-Bara Virus (EBV) 10 10 (100) 0 (0)

Cytomegalovirus (CMV) 10 10 (100) 0 (0)

Herpes Simplex Virus (HSV) I0 10 (100) 0 (0)

Parvovirus B 19 I10 10 (100) 0 (0)

Rubella 10 10 (100) 0 (0)

Syphilis 10 10 (100) 0 (0)

Toxoplasmosis 10 10 (100) 0 (0)

Human Immunodeficiency Virus (HIV-1/2) 154 154 (100) 0 (0)

Heterophilic antibodies 10 10 (100) 0 (0)

Multiparous Female 10 10 (100) 0 (0)

Total Samples Tested 405 405 0

None of the medical conditions tested produced false positive results in the OraQuick® HCV Rapid Antibody Test.Performance characteristics in scleroderma, Sjogren's Syndrome and Human T-Cell Lymphotropic Virus (HTLVI/lI) have not been established.

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SAMPLE STABILITYThe OraQuick® HCV Rapid Antibody Test was evaluated with whole blood stored at various storage conditionsover numerous days. Results are summarized in the table below.

Days at Storage ConditionSpecimen Type 2o-80c (36o46OF) 15o-30oc 59o.86F)

Whole Blood 7 3

Storing whole blood for up to 7 days refrigerated or 3 days incubated at 15°-30°C (59°-86°F) did not impact theperformance of the OraQuick® HCV Rapid Antibody Test.

SPECIMEN TYPESThe OraQuick® HCV Rapid Antibody Test was evaluated with whole blood samples collected in various types ofanticoagulants including Ethylenediaminetetracetic Acid (EDTA), sodium heparin, lithium heparin, and sodiumcitrate. Testing was performed with twenty anti-HCV negative whole blood samples and twenty anti-HCV-spikedpositive whole blood samples. All samples produced acceptable assay performance. The recommendedanticoagulant types for use with the OraQuick® HCV Rapid Antibody Test in whole blood are vacutainerscontaining EDTA, sodium heparin, lithium heparin, sodium citrate.

LIMIT OF DETECTIONThe limit of detection (LoD), defined as the EIA signal to cutoff ratio which yielded reactive results 95% of the timein the OraQuick® Rapid HCV Antibody Test device, was calculated for. each ofthree (3) lots separately and for three(3) lots combined. The LoD was calculated to be 0.75 s/co using an FDA approved EIA.

REPRODUCIBILITYThe reproducibility of the OraQuick® HCV Rapid Antibody Test was tested at 3 sites using 3 lots of test devicestwice a day for 5 days with 9 operators (3 per site). Three whole blood panel member types (negative, limit ofdetection (LoD), and low positive) were tested in 5 unique test kit types. Each test kit cdnsisted of eight (8) blindedpanel members that had various combinations of the 3 panel members in a randomized sequence. Panel memberswere blinded per operator, run, and device lot to ensure that the results of the panel member types wereunpredictable to the operator. LoD specimen was determined to be a 0.75 s/co by an FDA approved EIA. Overallconcordance across operators, sites, and device lots was 98.9% for the negative specimen, 98.7% for the specimen atthe limit of detection and 99.7% for the low positive specimen.

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BIBLIOGRAPHY1. CDC, Universal Precautions for Prevention of Transmission of Human Immunodeficiency Virus, Hepatitis

B Virus, and other Bloodbome Pathogens in Health-Care Settings. MMWR 1988; 37(24):377-388.2. Q-L Choo, AJ. Weiner, L.R. Overby, G. Kuo, M. Houghton, and D.W. Bradley, Hepatitis C Virus: The

Major Causative Agent of Viral Non-A, Non-B Hepatitis. British Medical Bulletin. 1990; Vol. 46, No.2:423441.

3. M.J. Alter, Ph.D., D. Kruszon-Moran, M.S., O.V. Nainan, Ph.D., G.M. McQuillan, Ph.D., F. Gao, M.D.,L.A. Moyer, B.S., R.A. Kaslow, M.D., M.P.H., and H.S. Margolis, M.D., The Prevalence of Hepatitis CVirus Infection in the United States, 1988 through 1994. The New England Journal of Medicine 1999; Vol.341, No. 8:556-562.

4. CDC, Updated U.S. Public Health Service Guidelines for the Management of Occupational Exposures toHBV, HCV, and HIV and Recommendations for Postexposure Prophylaxis. MMWR 2Q01; 50 (RR-I1):1-42.

5. L.M. Sehulster, F.B. Hollinger, G.R. Dreesman, and J.L. Melnick, Immunological and BiophysicalAlteration of Hepatitis B Virus Antigens by Sodium Hypochlorite Disinfection. Appl. Environ. Microbiol.1981; 42(5):762-767.

6. CDC, Guidelines for Laboratory Testing and Result Reporting of Antibody to Hepatitis C Virus. MMWR2003; 52(RR03): 1-16.

7. CDC, Recommendations for Prevention and Control of Hepatitis C Virus (HCV) Infection and HCV -Related Chronic Disease. MMWR 1998; 47(RR19): 1-39.

Manufactured by

OraSure Technologies, Inc.

Bethlehem, PA 18015 USA(610) 882-1820 · www.orasure.com

Item#3001-1530 (rev. 5/10)

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